Neomycin plus

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NEOMYCIN PLUS

Composition:

Active substances: 1 g of the preparation contains bacitracin zinc 250 IU, neomycin sulfate 5000 IU;

Excipients: light magnesium oxide, corn starch.

Pharmaceutical form. Topical powder.

Main physicochemical properties: fine, white to yellowish powder.

Pharmacotherapeutic group.
Antibiotics for topical use. ATC code D06AX.

Pharmacological Properties

Pharmacodynamics

Neomycin Plus is a combined antibacterial medicinal product for topical use, containing two bactericidal antibiotics with synergistic action. Bacitracin is a polypeptide antibiotic active primarily against Gram-positive microorganisms such as hemolytic streptococci, staphylococci, Clostridium spp., Corynebacterium diphtheriae, and Treponema pallidum, as well as against some Gram-negative pathogenic microorganisms such as Neisseria spp. and Haemophilus influenzae. The spectrum of activity also includes actinomycetes and fusobacteria. Bacitracin-resistant strains are rarely observed.

Neomycin is active against both Gram-positive and Gram-negative microorganisms, including staphylococci, Proteus, Enterobacter aerogenes, Klebsiella pneumoniae, Salmonellae, Shigellae, Haemophilus influenzae, Pasteurella, Neisseria meningitidis, Vibrio cholerae, Bordetella pertussis, Bacillus anthracis, Corynebacterium diphtheriae, Streptococcus faecalis, Listeria monocytogenes, Escherichia coli, Mycobacterium tuberculosis, Borrelia, and Leptospira icterohaemorrhagiae.

The combined use of bacitracin and neomycin provides a broad antimicrobial spectrum, although the preparation is inactive against Pseudomonas, Nocardia spp., fungi, and viruses.

Bacitracin and neomycin are generally not administered systemically. Topical application of the powder significantly reduces the risk of sensitization associated with systemic administration of antibiotics.

Pharmacokinetics

The medicinal product is well tolerated. Since absorption of bacitracin and neomycin through damaged skin is minimal, the maximum concentration of the drug is achieved at the site of application. Tissue tolerance is considered excellent, with no inactivation by biological products, blood, or tissue components reported. However, if the drug is applied to large areas of damaged skin, potential absorption and its consequences should be considered (see sections "Adverse Reactions" and "Special Warnings and Precautions for Use").

When used correctly, the drug exerts a local effect at the site of application. If absorption of the active substances occurs, the serum half-life of neomycin and bacitracin is approximately 2–3 hours.

Bacitracin is minimally absorbed through mucous membranes and skin. However, absorption through the skin may occur in the presence of open wounds.

Neomycin is absorbed in minimal amounts through intact skin. However, through inflamed or damaged skin and in the absence of the keratin layer (ulcers, wounds, burns), neomycin is rapidly absorbed.

Clinical characteristics.

Indications.

Bacterial infections of localized areas of the skin: bacterially infected simple herpes, herpes zoster/chickenpox; impetigo contagiosa; infected varicose ulcers; infected eczema; bacterially infected diaper dermatitis.

Prevention of umbilical infection in newborns.

As adjunctive therapy:

• following surgical (dermatological) procedures (including after excision and cauterization);
• in skin fissures;
• in perineal lacerations, episiotomy;
• in treatment of eroded wound surfaces (with exudate).

Contraindications.

Hypersensitivity to the components of the medicinal product or to other aminoglycoside antibiotics. Extensive and severe skin lesions (possible resorption of the drug and development of ototoxic effects leading to hearing loss). Do not use in patients with severe cardiogenic or nephrogenic excretory disorders when uncontrolled absorption of the drug is possible, as well as in patients with a history of vestibular and cochlear system disorders. Do not apply into the external auditory canal in cases of tympanic membrane perforation or to areas around the eyes.

Interaction with other medicinal products and other forms of interaction.

If systemic absorption occurs, concomitant use of cephalosporins or aminoglycoside antibiotics increases the risk of developing nephrotoxic reactions.

Concomitant use of diuretics such as ethacrynic acid or furosemide may enhance signs of oto- or nephrotoxicity.

In case of systemic absorption, concomitant use with opioid analgesics, analgesic agents, or muscle relaxants increases the risk of neuromuscular conduction disturbances.

Special precautions for use

The medicinal product must not be used in the oral cavity, especially in children.

When applying the product to patients with extensive skin lesions, one should consider the possibility of absorption of the active components of the product and, consequently, the development of ototoxic and/or nephrotoxic effects. Since the risk of toxic effects increases in patients with pronounced liver and/or kidney impairment, in such patients urine and blood parameters should be monitored, and audiometric examinations should be performed before and during intensive treatment with the product.

Precaution should be taken when using the product long-term in patients with chronic otitis media due to the possible ototoxic effect.

Concomitant use of systemic and topical aminoglycosides should be avoided due to the risk of cumulative toxicity.

If uncontrolled absorption of the product occurs, the possibility of neuromuscular blockade should be considered, especially in patients with acidosis, a history of severe myasthenia (Myasthenia gravis), or other neuromuscular disorders. Neuromuscular blockade can be reversed by calcium preparations or by proserin (neostigmine).

With prolonged treatment, overgrowth of resistant microorganisms and fungi may occur. In such cases, appropriate therapy should be initiated.

The product should be discontinued in patients who develop hypersensitivity or superinfection.

Phototoxic reactions or photosensitization may occur following exposure to sunlight or UV radiation.

Use during pregnancy or lactation

The powder may be used during pregnancy or breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus or infant, and if there is a risk of absorption of the active substances. Like other aminoglycoside antibiotics, neomycin crosses the placental barrier. There have been reports of hearing impairment in the fetus following systemic administration of high doses of aminoglycosides.

Before breastfeeding, any residual product should be removed from the mammary gland using boiled water and sterile cotton.

Ability to affect reaction rate when driving or operating machinery

Unknown.

Method of Administration and Dosage

For adults and children from birth, Neomycin Plus powder is usually administered 2–4 times daily.

During treatment, it is recommended to apply the powder to an area of skin not exceeding 1 % of the body surface area (corresponding to the size of the palm).

After application of the powder to affected skin areas, the natural evaporation process (sweating) is activated, thus the medicinal product exerts a cooling and soothing effect.

The powder should be evenly spread over the area to be treated. If necessary, a gauze dressing may be applied after application of the product to the affected area.

Patients with burns covering more than 20 % of the body surface should use Neomycin Plus powder no more frequently than once daily, especially if renal function is impaired, as absorption of the active substances of the product may occur.

When used topically for more than 7 days, the dose of neomycin should not exceed 1 g per day (equivalent to 200 g of powder). For repeated courses, the maximum dose should be halved.

Elderly patients (aged 65 years and older). Dose adjustment in elderly patients is not required.

Children.

Can be used in children from the first days of life as prescribed by a physician, after careful assessment of the benefit-risk ratio.

Overdose.

With administration of doses significantly exceeding the recommended ones, symptoms indicating nephro- and/or ototoxic reactions should be considered due to possible absorption of the active substances of the medicinal product, especially in patients with trophic ulcers.

Treatment: symptomatic therapy.

Side effects.

The frequency of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10,000, < 1/1000), very rare (< 1/10,000), frequency not known (cannot be estimated from the available data).

The drug is generally well tolerated when applied topically.

Immune system disorders:
Rare – in cases of allergic reactions to neomycin, cross-allergy to other aminoglycoside antibiotics occurs in approximately 50% of cases; frequency not known – hypersensitivity to neomycin and many other substances may occur when the drug is used in chronic dermatoses or chronic otitis media. Under certain circumstances, allergy may manifest as lack of successful wound healing.

Nervous system disorders:
Frequency not known – vestibular nerve damage, neuromuscular blockade.

Ear and labyrinth disorders:
Frequency not known – ototoxicity.

Skin and subcutaneous tissue disorders:
Rare – allergic reactions, mainly presenting as contact dermatitis. Allergic reactions caused by neomycin occur less frequently than generally assumed; frequency not known – prolonged use may lead to allergic reactions such as redness, dryness and peeling of the skin, rash, itching. Spread of lesions or lack of healing may be due to allergy. Phototoxic or photoallergic reactions cannot be excluded upon exposure to sunlight or ultraviolet radiation.

Renal and urinary disorders:
Frequency not known – nephrotoxicity.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the drug. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all cases of suspected adverse reactions and lack of drug efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 g in a container or in a bottle; 1 container or bottle in a cardboard box.

Availability. Over-the-counter.

Manufacturer.

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business.

Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenko Street, 22.